Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

• Occurence of adverse events and serious adverse events during the study [ Time Frame: Duration of participation in study ] [ Designated as safety issue: Yes ]
• Annualized bleed rates [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
• Response to first on-demand treatment with test article for all new bleeding episodes [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
• number of test article infusions required for each bleeding episode [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
• number of breakthrough bleeding episodes within 48 hours of a prophylaxis treatment [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
• Average infusion dose and the total factor consumption [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
• Incidence of less-than-expected-therapeutic effect (LETE) [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]

The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.

The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in March 2013 was agreed with EMA prior to closure activity.

• Drug: moroctocog alfa (AF-CC) (ReFacto AF)
  Providing moroctocog alfa (AF-CC) as test article for use during this study.
• Procedure: Laboratory tests
  Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.

Inclusion Criteria:

• Male patients greater than or equal to 12 years of age with severe hemophilia A (FVIII:C less than 1%).
• Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII replacement products.
• Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.
• Serum albumin greater than or equal to the lower limit of normal (LLN).
• Platelet count greater than or equal to 100,000/µL.
• Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized ratio (INR) less than or equal to 1.5.
• HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load less than 200 particles/µL.

Exclusion Criteria:

• Presence of any bleeding disorder in addition to hemophilia A.
• A positive FVIII inhibitor, according to the local laboratory, at screening; or any Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the testing laboratory.
• Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI]) during the screening period.
• Prior exposure to moroctocog alfa (AF-CC).
• Known hypersensitivity to hamster protein.